Swierkot 2009.
Study characteristics | ||
Methods |
Study design: RCT with 3‐arm parallel design Recruitment period: unclear Setting: university dental department, Marburg, Germany Number of centres: 1 Funding source: supported by university |
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Participants |
Inclusion criteria: diagnosis of chronic periodontitis with PD ≥ 5 mm and BOP. All participants in good general health Exclusion criteria: antibiotics from 6 months before or during study, history of systemic disease, people attending for orthodontic treatment, pregnancy Age: 28–63 years Sex: 20 F (FMS: 7; FMD: 7; control: 6) and 5 M (FMS: 2; FMD: 2; control: 1) Smokers: 5 (FMS: 3; FMD: 1; control: 1) (smoking ≥ 10 cigarettes per day) Number randomised: 25 (FMS: 9 FMD: 9; control: 7) Number evaluated: 25 (FMS: 9 FMD: 9; control: 7) |
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Interventions |
Comparison: FMS vs control; FMD vs control; FMS vs FMD FMS group: (FM‐SRP): 2 sessions within 24 hours FMD group: (FMD) 2 sessions scaling within 24 hours; after instrumentation: tongue brushing: CHX 1%, 1 minute; rinse: CHX 0.2%, twice for 1 minute; spray pharynx: CHX 0.2% 4 × each, subgingival: CHX 1%. Home: rinse CHX 0.2%, 1 minute, 2 × day, 14 days; spray tonsils: CHX 0.2%, 1 × day, 14 days Control group: (Q‐SRP) 4 sessions Q wise, 1‐week interval starting first Q, hand and US instruments OHI before study start: yes Instruments used: hand and US instruments Time per Q: unclear Maintenance: 1, 2, 4 and 8 months Retreatment: none Duration of study: 8 months |
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Outcomes |
Primary outcome: PPD (4 sites per tooth) Secondary outcomes: CAL, BOP (4 sites per tooth). Manual probe for all measurements Teeth: whole‐mouth recordings (baseline, 1, 2, 4 and 8 months). Data split in single‐ and multi‐rooted teeth for moderate (4–6 mm) pockets and whole‐mouth recordings for deep (≥ 7 mm) pockets Pocket depth at baseline: moderate (PPD 4–6 mm) and deep pockets (PPD ≥ 7 mm) Outcome time reported: 4 and 8 months used. 1, 2, 4 and 8 months measured Other outcomes: PLI, API, microbiology |
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Notes | Blinding unclear. Exclusion of third molars, as well as teeth with furcation degree II and III | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The randomisation was performed with a combination of coin toss and drawing of lots by a second person not involved in the study to assign the patients into the following groups: full mouth disinfection (FMD), FM‐SRP (FMS) and Q‐SRP (control)". |
Allocation concealment (selection bias) | Low risk | Quote: "The sequence was concealed until interventions were assigned". |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "The treatment and reassessment were performed by one periodontist who had been trained and tested previously for his reproducibility". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "One patient in every group was excluded from the study due to prescribed antibiotics because of sinusitis maxillaris. The patient of the FM‐SRP group dropped out 2 months after treatment and the two patients of the other two groups dropped out 4 months after treatment. Their data were not included into the statistical analysis". |
Selective reporting (reporting bias) | Low risk | Data reported on all primary and secondary outcomes. |
Other bias | Low risk | Baseline balance good for pocket depth and smoking. No apparent other biases. |